MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to crush a large stone.However, the basket was unable to crush the stone and the tip failed to detach.To remove the basket and stone from the patient, an emergency lithotripsy system was used over the trapezoid basket after breaking the "maneuver for removal" and the procedure was completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 2547 captures the reportable event of tip failure to separate.The returned trapezoid rx was analyzed, and a visual evaluation noted that only the pull wire (basket-wire) was returned.The handle, handle cannula, and sheath were separated from the device and were not returned for analysis.The pull wire was cut at the proximal section.Marks observed at the cut area indicate that an unknown tool was used to cut the device.The pull wire was found kinked at several locations.The basket was also found kinked; however, the tip is still attached to the basket wires assembly.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can kink the pull wire and basket wires.This device condition indicates that there could have been resistance during handle actuation, which may cause the force applied to the handle to not reach the distal section of the device generating the reported issue.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to crush a large stone.However, the basket was unable to crush the stone and the tip failed to detach.To remove the basket and stone from the patient, an emergency lithotripsy system was used over the trapezoid basket after breaking the "maneuver for removal" and the procedure was completed.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9282339
• MDR Text Key: 183007392
• Report Number: 3005099803-2019-05383
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0022999381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR